What About Fosamax — Can the treatment be as bad as the disease?

Fosamax is the oldest, most prescribed and most studied of the bisphosphonate drugs (BPs) used to treatment “porous bone” or osteoporosis.

The other bisphosphonate drugs used to treat osteoporosis include Fosamax Plus D, Actonel, Actonel with Calcium, Atelvia, Boniva and Reclast.

Osteoporosis is a bone weakening condition that affects almost 10 million women in America and causes approximately 1.5 million fractures each year.

Since 2008, concerns over Foxamax and other BPs have been raised by medical doctors  who noted  atypical fractures to  the femur (thigh bone) experienced by some long term users of the drug.  According to Harvard Health Publications, researchers in Singapore in 2008 reported 17 postmenopausal women who had taken Fosamax for an average of 5 years experienced atypical fractures of the femur (i.e. fractures not caused by major physical injury).  Harvard Health Publications reports: “… given what we know about the effects of bisphosphonates on bone remodeling, the findings seem plausible.  In the short term, slowing bone resorption increases bone density. But in the long run, it may impair new bone formation and reduce the bone’s ability to repair microscopic cracks from wear and tear.” Harvard Health Publications, Health.harvard.edu/newsletters.

Later, doctors at New York’s Hospital for Special Surgery reviewed patient charts from 2002 to 2007 and identified some 70 patients with atypical fractures.  More than a third of the 70 patients who suffered atypical fractures had been taking Fosamax and and 4/5^th of those were fractures of the femur .  Significantly, 95% of the atypical femur fractures occurred in patients who had taken Fosamax for an average of 7 years.

On September 14, 2010, the American Society of Bone and Mineral Research (the leading organization concerning the science of bones)  issued a report calling for additional BP product labeling and an international patient registry. This was after the task force reviewed 310 cases of atypical femur fractures and found that 94% of the patients had taken a BP, most for more than five years. The task force found that many of the patients with atypical femur fractures had experienced groin or thigh pain for weeks or months before the fracture and that more than 25% of the patients had experienced fractures in both legs.

On October 13,2010, the FDA issued a Safety Announcement noting that while atypical fractures appear in less than 1% of the hip and femur fractures overall, “these unusual femur fractures have been predominantly reported in patients taking bisphosphonates such as Fosamax.”

The FDA also set forth that:

Although the optimal duration of bisphosphonate use for osteoporosis is unknown, these atypical fractures may be related to long-term bisphosphonate use.  FDA will require a new Limitations of Use statement in the Indications and Usage section of the labels for these drugs.  This statement will describe the uncertainty of the optimal duration of use of bisphosphonates for the treatment and/or prevention of osteoporosis.

A Medication Guide will also be required to be given to patients when they pick up their bisphosphonate prescription.  This Medication Guide will describe the symptoms of atypical femur fracture and recommend that   patients notify their healthcare professional if they develop symptoms.

The FDA issuance of the Safety Statement is part of its ongoing safety review of BP use and its relation to atypical femur fractures.

If you are currently taking Fosamax or one of the other BPs listed above, you should:

• Immediately report any unusual symptoms to your doctor (especially groin or leg pain;
• Review your treatment plan at least yearly with your doctor;
• Eat a balanced diet that contains fruits, vegetables, low-fat or fat-free calcium rich foods;
• Engage in regular (at least 3 times a week) weight-bearing exercise;
• If you are under 50, take 1000mg of calcium and 400-800 IU of Vitamin D daily;
• If you are 50 or older, take 1200 mg of calcium and 800-1000 IU of Vitamin D daily;
• If you smoke, try to quit and limit your intake of alcohol.